Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Local Control ( LC )
研究概览
简要总结
In this study, The researchers sought to explore the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients among different groups which include drug therapy alone, radiotherapy alone, and drug therapy plus radiotherapy by inviting clinical multi-center participation.
详细描述
The recurrent or refractory ovarian cancer tends to recur repeatedly at increasingly short intervals, making treatment more and more difficult.Patients often have limited physical capacity to undergo repeated systematic treatment. Currently, NCCN（ national comprehensive cancer network ）guidelines recommend palliative radiotherapy in patients with local recurrence of ovarian cancer. With the progress of IMRT（ intensity modulated radiation therapy ）, SBRT ( stereotactic body radiation therapy ) and other radiotherapy technologies, better local tumor control rate can also be achieved, while minimizing the damage to surrounding normal tissues. In this study, the patients will be divided into groups according to their wishes: group A (drug therapy alone), group B (radiotherapy alone), and group C (radiotherapy plus drug therapy).The researchers sought to explore the the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients in different groups after treatment by inviting multiple centers to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Evidence of histological diagnosis of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
- •Pathology or imaging suggested recurrence, with measurable lesions, and the number of lesions ≤3;
- •No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney and immune deficiency
- •Cooperative Oncology Group-Status (ECOG Status) score 0-2;
- •Expected survival ≥3 months;
- •Feasible abdomen and pelvic cavity MRI/CT;
- •Good compliance, signed informed consent voluntarily.
排除标准
- •Previous radiotherapy at the target lesion site;
- •History of active inflammatory bowel disease or severe stomach and duodenal ulcers;
- •Human immunodeficiency virus (HIV) infected persons;
- •active hepatitis b (HBVDNA quantitative test results exceed the lower limit), or HCV infection (HCVRNA quantitative test results exceed the lower limit);
- •suffering from serious underlying diseases, including but not limited to active infections requiring systemic medication:
- •patients with a history of other malignant tumors (except cured basal cell carcinoma of the skin);
- •neurological or mental disorders that affect cognitive ability;
- •Patients whose lesions have been evaluated by the investigator and cannot be treated with external irradiation or endovascular radiation therapy;
- •those who cannot follow up regularly as prescribed by the doctor;
- •Other reasons not suitable for participating in this study as judged by the researcher.
研究组 & 干预措施
Group A (drug treatment group)
Group A (drug treatment group) : Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary.
干预措施: chemotherapy, targeted therapeutics, immunotherapy (Drug)
Group B (radiotherapy group)
IFRT, IMRT or SBRT is applied. Irradiation techniques and doses can be selected based on the previous experience of each center, but all patients enrolled within the center need to be consistent.
干预措施: IFRT, IMRT or SBRT (Radiation)
Group C (radiotherapy + drug group)
Drug therapy is the same as group A; IFRT is the same as group B.
干预措施: chemotherapy, targeted therapeutics, immunotherapy (Drug)
Group C (radiotherapy + drug group)
Drug therapy is the same as group A; IFRT is the same as group B.
干预措施: IFRT, IMRT or SBRT (Radiation)
结局指标
主要结局
Local Control ( LC )
时间窗: 6 months
LC will be measured from the start date of treatment until the date of progressive of the target lesion
次要结局
- Progression-free Survival ( PFS )(24 months)
- Overall Survival ( OS ）(24 months)
- Rate of Radiation-related Adverse Reactions(24 months)
研究者
Liu Zi
Professor
Health Science Center of Xi'an Jiaotong University